Valneva has unveiled updates on its Covid-19 vaccine, the first to get full light for commercialization in Europe, but the French biotech halted production last year due to reduced order volume in the EU.
The company said it extended the shelf life of the vaccine by 3 months, from 18 to 21 months. He also stated that the Committee of the European Medicines Agency had issued a favourable opinion on the use of the vaccine, VLA2001, as a booster dose in adults. Over 18 to 50 years old.
In a phase III trial of the vaccine, Valneva said it is not inferior to AZD1222, the Oxford-AstraZeneca pandemic vaccine.
A new partnership would be needed for Valneva to invest more in its vaccine, the company said in the past. — Kyle LaHucik
The contract study organization ClinChoice, which has close ties to the U. S. , has been given a major by the U. S. The U. S. and China incorporate CRO.
ClinChoice announced Wednesday that it will get its hands on CROMSOURCE, another U. S. -based clinical trials organization. A ClinChoice member added that the acquisition will “strengthen ClinChoice’s global network and deepen its full-service capabilities. “
ClinChoice Chairman and CEO Ling Zhen, who told Endpoints News last year that he would consider geographic expansion, said the acquisition “gives us a highly experienced team of technical and operational experts in Europe and North America. “
Financial knowledge for the undisclosed agreement.
ClinChoice raised $150 million in a Series E last year to continue its expansion plans, J’s wife, Legend Biotech.
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Alfredo Najá Domingos’ prostate cancer is spreading. Malignant cells permeated his bones, kidneys, lungs and liver, and in December his oncologist told him he didn’t want to continue chemotherapy treatment.
But there was a new remedy he could try: targeted radiation called Pluvicto, if he gets it in time. The Moffitt Cancer Center and Mayo Clinic in Florida, not far from Domingos and his family, said he would have to wait between three-and-a-half and four months to get the remedy. His wife, Nora Flor, said she and her sister had called at least 30 centers in the U. S. U. S. in search of the drug.
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Issi Rozen is as deeply rooted in the gene-editing box as he is in the bustling biotech hub of Cambridge, MA. As Broad’s chief commercial officer and chief strategy officer for a decade, he has worked with all the big names in a clinical field. which promises to interrupt the healing box, eventually. He is even a co-founder of Verve, which carries the banner of fundamental publishing.
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Novo Nordisk expands its R business
The company announced the creation of more than two hundred new jobs, adding approximately 150 for research in knowledge sciences, biology or chemistry and R
But now that Boston will be R’s
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Emil Kakkis, CEO of rare disease drug maker Ultragenyx Pharmaceuticals, sat down with Endpoints News in Washington, D. C. to talk about the industry’s latest struggles around the emergence of rare and ultra-rare disease drugs, the need for the Orphan Drug Act 2. 0, and why the FDA wants to qualify more biomarkers and pave the way for accelerated approval.
At least 30 rare disease drug systems were shut down over the past year, Kakkis said, noting that the approval procedure is more complicated in some cases because the FDA raises the bar or the money is too high.
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The United States has contributed at least $31. 9 billion in public investment to the progression of mRNA-based COVID-19 vaccines, according to a new BMJ study.
That at least $337 million in the 3 decades leading up to the pandemic, wrote seven researchers from the Brigham and Women’s Program On Regulation, Therapeutics, And Law (PORTAL).
For co-author and number one care physician Hussain Lalani, the study began as a way to understand the origins of mRNA vaccines and make patients realize that Covid shots weren’t created overnight.
Intellia Therapeutics announced Thursday morning that the FDA has authorized gene-editing treatment for hereditary angioedema (HAE) in clinical trials in the United States. The Cambridge, MA-based biotech is already conducting the trial in New Zealand, the Netherlands and the United Kingdom. .
Intellia’s HAE remedy, known as NTLA-2002, is the first in vivo gene-editing remedy delivered via lipid nanoparticles approved by the FDA for human trials. Lipid nanoparticles, or LNPs, are tiny balls of fatty acids that have been used by automobiles in Covid mRNA vaccines.
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Generic drugmaker Akorn Pharmaceuticals has filed for bankruptcy and will sell its services across the United States, liquidate its assets and shut down operations, it said in a court filing.
According to an undated letter from CEO Douglas Boothe via the Illinois Herald news site.
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Almost exactly a year after MorphoSys $MOR signaled the withdrawal of startups, recouped its $1. 7 billion purchase of Constellation and targeted its operations in Germany, biotech is back with another R recession.
MorphoSys executives said Thursday morning they would eliminate all preclinical efforts as part of a cost-cutting measure, laying off 17 percent of their work, without specifying the number, and bolstering their focus of studies around mid- and late-stage clinical work.
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